1. Field of the Invention
The present invention relates to a reaction analysis kit for analyzing biological substances, such as nucleic acids, proteins and microorganisms as well as a reaction analysis system to which the kit is applied. The reaction analysis kit and system according to the present invention allow inexpensive, simple, highly sensitive, quick analysis by applying a chemical luminescence reaction and an optical sensor chip having a wireless communication capability to immunochromatography.
2. Background Art
In analyte tests for disease markers for adult diseases, tumors and the like as well as viruses and bacteria, there have been conventionally used centralized testing apparatuses installed mostly in large hospitals and test centers from the viewpoint of cost reduction through labor saving. However, anti-influenza virus agents developed in late 1990s have required quickness in which the species of virus in question is identified at the point of care and an antiviral drug is prescribed at the same time. Inexpensive immunochromatography characterized by simplicity and acceptable sensitivity has responded to this request, resulting in rapid proliferation. POCT (Point of Care Testing) is expected to be increasingly popular in the future in various fields, such as prevention and treatment of lifestyle-related diseases including infectious diseases and cardiac infarction, and immunochromatography is expected to be one of promising POCT devices.
Immunochromatography is an inexpensive, simple technique suitable for on-site test kits. However, since immunochromatography relies on a coloring reaction visually detected, it is less sensitive than centralized test apparatuses and has difficulty in quantification. Although widely used immunochromatography test agents for influenza viruses can quickly indicate whether or not an analyte in question is infected with viruses within 15 minutes (Kawakami, et al., Influenza, 6(4), page 35, (2005)), it provides a false negative when the analyte has few viruses during the initial infection stage (Nikkei Medical, November, page 46, (2003)), so that it is desirable to improve the sensitivity (Nikkei Medical, February, page 54, (2003)). For cardiac infarction, which is one of representative lifestyle-related diseases, high correlation has been found between disease markers, such as troponin and myoglobin, and the risk of the onset of serious blood clot (E. M. Ohman, et al., N. Engl. J. Med., 335, page 1333, (1996), R. H. Christenson, et al., Clinical Chemistry, 44(3), page 494, (1998), and P. Stubbs, et al., Circulation, 94(6), page 1291, (1996)). When a patient having the risk feels chest discomfort, it is desirable to quickly perform quantitative measurement of the disease markers.
In view of the above background, there have been proposed more sensitive test apparatuses for quantitative measurement in tests of disease markers, viruses, bacteria and the like. For example, to maintain inexpensiveness and simplicity of immunochromatography and allow highly sensitive, quantitative measurement, there have been proposed methods including the steps of using an immunochromatography-based membrane, applying light to the membrane material using a light emitting diode (LED) or a laser diode (LD), and detecting the reflected light using a photodiode (PD) and digitizing the grayscale of the coloring reaction or fine particle aggregation (JP Patent Publications (Kokai) No. 2004-170217 A, No. 2005-077264 A, and No. 10-274624 A). However, since these apparatuses are configured to read reflected or transmitted light generated in immunochromatography test drugs, an optical window for the membrane needs to be provided to illuminate the membrane with the light from the LED/LD, resulting in limitation in terms of reduction in cost and size. Furthermore, since the mechanism of a coloring reaction or fine particle aggregation is used, as in conventional immunochromatography using visual inspection, it is difficult to achieve the performance of large-sized centralized test apparatuses in terms of sensitivity and the dynamic range.
Although a sensor element having a wireless communication capability and an optical sensing capability is known as a non-visual test (JP Patent Publication (Kokai) No. 2004-0101253 A), there has been no report of applying this technique to immunological test apparatuses. Even if the technique is applied to such an immunological test apparatus, there still remain problems of bulkiness and limitation of the sensitivity of the apparatus.